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Wednesday, April 15, 2009

New FDA Data: Adverse Event Reporting Increases Dramatically

The FDA received nearly half a million (496, 412) adverse event reports (AERs) in 2008, which is nearly a third (32%) more than it received in 2007 (376,902). By comparison, the 2007 number was only 20% higher than the 2006 number.

The definition of "adverse event" for both nonprescription drugs and dietary supplements is "any health-related event associated with the use of a [nonprescription or dietary supplement] that is adverse" (see source). This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.

The chart below shows AER data from the FDA for the period 1998 through 2008, as updated on April 6, 2009.

Click on image for an enlarged view.

"These data," says FDA, "describe information about the reporter – the person who submitted the report to FDA, or the person who submitted the report to the manufacturer (who then sent the report to FDA). Physicians and pharmacists are the healthcare providers (HCP) who submit reports to FDA most frequently. Other Healthcare Providers include nurses, dentists and others. Consumer refers to any reporter who is not documented in the report as a healthcare provider. This figure includes only data where reporter information is known, and some adverse event reports may contain more than one reporter."

Why did the number of AERs increase so dramatically in 2008?

"Other Healthcare Professionals" may be partly responsible for the increase. AERs submitted by this group increased by 47% in 2008 v. 2007 (data not shown but available here). This compares to a 27% to 33% increase in AERs received from other reporters.

The FDA's use of technology to reach out to the public (see "FDA's Use of Social Media"; PMN Reprint#83-03) may also have made it easier to submit adverse event reports.

Whatever the cause, the drug industry is concerned and often cites AERs as a major reason why it has not engaged in social media as aggressively as it could.

But adverse event reporting requirements are just the tip of the iceberg that is the barrier to pharmaceutical use of social media for healthcare marketing and communications. For more on that and some ideas for overcoming this barrier, listen to this ePharma Pioneer Club roundtable discussion (podcast).

5 comments:

  1. Hi John,
    Great Post. I looked at the data myself and my conclusion in regards to blaming Social Media is that it's not the case (yet). For one, I believe that it's still too early to evaluate the impact of SM on CONSUMER AER as we are just dabbling into it. Second, looking at the data, you will see that the uptake on the consumer reporting their AERs started in 2003 and was at a much higher pace during the 2003-2005 period. The curve is still steep in the recent years (07, 08) tough.
    Any thoughts?

    ReplyDelete
  2. Xavier,

    Well 2003-2005 was the "Vioxx recall era" and a lot more attention was drawn to drug safety. I haven't looked deeply into the timing of FDA's new tools that made it easier for consumers (and others) to report AEs to see if there is a correlation or not.

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  3. John,

    There's a theme here that I don't (I hope) is the reason that AE's continue to be cited as a barrier to Social Media participation. The legitimate reason for companies to have concerns about AE's relates to their ability to have a systematic approach to be in AE reporting compliance and not to solicit unverifiable AEs (bad quality reports). Implied in a lot of conversation is that companies just don't want the potential increased volume of AE reports. That's like saying "I don't want to know how unsafe my drug is." If FDA's use of technology has increased the volume of reporting, that's exactly what was intended. I'll remain optimistic that companies have the right reasons for citing AE reporting as a barrier to social media (companies cannot set up a system that has foreseeable built-in non compliance for AE reporting). Thanks for data mining the data mining.

    John Murray

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  4. I'm coming at this from the Social Media side of the equation as opposed to the Pharma side. If you go to "search.twitter.com" and type "gave me a rash" as a search phrase, the results will show plenty of products that give people rashes. Could these findings qualify as an adverse affect that needs to be reported--even though the statement is just a cry in the wilderness without being directed to anyone in particular? If so, who is responsible for reporting it the the FDA?

    ReplyDelete
  5. pharmaguy,

    you can search the AERS database here:

    e.g., here's a search for Adverse Events reported where viagra was taken...

    http://www.fdable.com/aers/query/1aa845408fc6

    ReplyDelete

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